Trial Outcomes & Findings for Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain (NCT NCT01539863)

NCT ID: NCT01539863

Last Updated: 2023-10-16

Results Overview

Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 328 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-10-16

Participant Flow

Patients with persistent or recurrent LBP were screened for eligibility in a stepwise manner (at Baseline 1, Baseline 2 and inclusion visit). The study started at the inclusion visit, when the initial treatment plan was completed when the clinician perceived that the patient's next visit could be scheduled with an interval of 1 month or longer, at which patients were randomly allocated to one of the treatment arms. Recruitment lasted from 2012 to 2016, in 40 Swedish chiropractic clinics.

Some individuals were lost in the inclusion process: At the 4th visit (baseline 2) a total of 616 subjects were screened for definite improvement, where 176 subjects were excluded from the trial. At the inclusion visit, 328 subjects were randomized into the trial, thus another 112 subjects were lost for unknown reasons.

Participant milestones

Measure	Treatment at Regular Intervals Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor	Treatment as Needed Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration Treatment as needed: Participants may never receive treatment, there is no upper limit
Overall Study STARTED	166	162
Overall Study COMPLETED	161	158
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	Treatment at Regular Intervals Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor	Treatment as Needed Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration Treatment as needed: Participants may never receive treatment, there is no upper limit
Overall Study Lost to Follow-up	5	4

Baseline Characteristics

4 individuals declined participation after randomization

Baseline characteristics by cohort

Measure	Treatment at Regular Intervals n=164 Participants Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor	Treatment as Needed n=160 Participants Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration Treatment as needed: Participants may never receive treatment, there is no upper limit	Total n=324 Participants Total of all reporting groups
Age, Continuous	43.4 years STANDARD_DEVIATION 11.7 • n=164 Participants • 4 individuals declined participation after randomization	43.0 years STANDARD_DEVIATION 13.1 • n=160 Participants • 4 individuals declined participation after randomization	43.3 years STANDARD_DEVIATION 12.4 • n=324 Participants • 4 individuals declined participation after randomization
Sex: Female, Male Female	96 Participants n=150 Participants • Information about gender was not available for all subjects	85 Participants n=141 Participants • Information about gender was not available for all subjects	181 Participants n=291 Participants • Information about gender was not available for all subjects
Sex: Female, Male Male	54 Participants n=150 Participants • Information about gender was not available for all subjects	56 Participants n=141 Participants • Information about gender was not available for all subjects	110 Participants n=291 Participants • Information about gender was not available for all subjects
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	164 participants n=164 Participants	160 participants n=160 Participants	324 participants n=324 Participants

PRIMARY outcome

Timeframe: 12 months

Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks.

Outcome measures

Measure	Treatment at Regular Intervals n=161 Participants Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor	Treatment as Needed n=158 Participants Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration Treatment as needed: Participants may never receive treatment, there is no upper limit
Number of Days With Bothersome Low Back Pain	85.2 Number of days with bothersome pain Interval 83.5 to 87.0	98 Number of days with bothersome pain Interval 95.9 to 100.1

SECONDARY outcome

Timeframe: 12 months

Cost-effectiveness will be based on Quality Adjusted Life Years calculated through the use of the Euroqol-5 instrument, these results are not yet published

Outcome measures

Outcome data not reported

Adverse Events

Treatment at Regular Intervals

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Treatment as Needed

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment at Regular Intervals n=164 participants at risk Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor	Treatment as Needed n=160 participants at risk Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration Treatment as needed: Participants may never receive treatment, there is no upper limit
Musculoskeletal and connective tissue disorders Minor	26.2% 43/164 • Number of events 43 • 12 months	25.0% 40/160 • Number of events 40 • 12 months

Additional Information

Ass professor Iben Axén

Karolinska Institutet

Phone: +46704400618

Email: iben.axen@ki.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place